{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,6]],"date-time":"2026-04-06T03:23:42Z","timestamp":1775445822074,"version":"3.50.1"},"reference-count":69,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2023,12,10]],"date-time":"2023-12-10T00:00:00Z","timestamp":1702166400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000921","name":"European Cooperation in Science and Technology","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000921","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,1,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Perinatal derivatives have been proposed as adjunct therapeutic strategies or innovative treatments. Undoubtedly, perinatal derivatives can offer the opportunity and source material to isolate multipotent stem cells, but both maternal- and fetal-derived tissues can be processed and transformed into engineered tissues or advanced biomedical devices, whose potential remains to be fully elucidated. Promising preclinical and clinical results collected so far clearly foresee an escalation of such novel treatments. Market forecasts predict exponential growth in such advanced medicinal products during the next decade, with a pragmatic innovation for medicine into a more advanced biomedical version, enlarging the portfolio for treating a wide range of congenital and acute conditions. However, all these promising and fascinating therapeutic possibilities cannot gain a solid and recognized role in established medical practice without rigid and harmonized manufacturing strategies. The implementation of strategies according to guidelines and directives compiled by Regulatory Agencies, in conformity to (European) Pharmacopoeia and for Good Manufacturing Practice -conforming production of such products, represent critical steps required to translate perinatal technologies into effective therapeutic approaches. During the past 5 years, a panel of European experts and developers, gathered under the umbrella of the COST Sprint Action, supported by the European Cooperation in Science and Technology action, had the opportunity to revise and summarize experience and recommendations for a fruitful and proficient generation of perinatal biomedical products. In order to facilitate the creation and potential commercialization of perinatal bioengineered and advanced pharmaceutical products and technologies, such a collection of data and recommendations is described and discussed here.<\/jats:p>","DOI":"10.1093\/stcltm\/szad068","type":"journal-article","created":{"date-parts":[[2023,12,10]],"date-time":"2023-12-10T07:23:56Z","timestamp":1702193036000},"page":"14-29","source":"Crossref","is-referenced-by-count":8,"title":["Expert Revision of Key Elements for Clinical-Grade Production and Qualification of Perinatal Derivatives"],"prefix":"10.1093","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3362-4170","authenticated-orcid":false,"given":"Roberto","family":"Gramignoli","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine, Division of Pathology, Karolinska Institutet , Stockholm , Sweden"},{"name":"Department of Pathology and Cancer Diagnostics, Karolinska University Hospital , Stockholm , Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5281-1361","authenticated-orcid":false,"given":"Nicola","family":"Hofmann","sequence":"additional","affiliation":[{"name":"German Society for Tissue Transplantation (DGFG) gGmbH , Hannover , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marta","family":"Agudo-Barriuso","sequence":"additional","affiliation":[{"name":"Experimental Ophthalmology Group, University of Murcia and Instituto Murciano de Investigaci\u00f3n Biosanitaria (IMIB) , Campus Ciencias de la Salud, Murcia , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariastefania","family":"Antica","sequence":"additional","affiliation":[{"name":"Ruder Boskovic Institute, Division of Molecular Biology , Zagreb , Croatia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana I","family":"Flores","sequence":"additional","affiliation":[{"name":"Regenerative Medicine Group, Research Institute Hospital 12 de Octubre (imas12) , Madrid , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lenart","family":"Girandon","sequence":"additional","affiliation":[{"name":"Educell Ltd., R&D Department , Trzin, Slowenia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Halima","family":"Kerdjoudj","sequence":"additional","affiliation":[{"name":"University of Reims Champagne Ardenne, EA 4691 BIOS , Reims , France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruta","family":"Navakauskiene","sequence":"additional","affiliation":[{"name":"Department of Molecular Cell Biology, Institute of Biochemistry, Life Sciences Center , Vilnius , Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Schiavi","sequence":"additional","affiliation":[{"name":"Department of Bioprocesses Biomolecules, University of Lorraine, CNRS, LRGP , Nancy , France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanne","family":"Scholz","sequence":"additional","affiliation":[{"name":"Department of Transplant Medicine, Department of Cellular Therapy, University of Oslo , Oslo , Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Volodymyr","family":"Shablii","sequence":"additional","affiliation":[{"name":"Laboratory of Biosynthesis of Nucleic Acids, Institute of Molecular Biology and Genetics, Department of Functional Genomics, National Academy of Science , Kyiv , Ukraine"},{"name":"Placenta Stem Cell Laboratory, Cryobank, Institute of Cell Therapy , Kyiv , Ukraine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xavier","family":"Lafarge","sequence":"additional","affiliation":[{"name":"Etablissement Fran\u00e7ais du Sang Nouvelle-Aquitaine, Laboratoire d\u2019ing\u00e9nierie tissulaire et cellulaire , Bordeaux , France"},{"name":"INSERM U1211 \u00ab Maladies Rares: G\u00e9n\u00e9tique et M\u00e9tabolisme \u00bb , Universit\u00e9 de Bordeaux , France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francisco J","family":"Nicol\u00e1s","sequence":"additional","affiliation":[{"name":"Lab. Regeneraci\u00f3n, Oncolog\u00eda Molecular y TGF\u00df. IMIB-Pascual Parrilla, El Palmar , Murcia , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florelle","family":"Gindraux","sequence":"additional","affiliation":[{"name":"CHU Besan\u00e7on, Service de Chirurgie Maxillo-Faciale, Stomatologie et Odontologie Hospitali\u00e8re , F-25000 Besan\u00e7on , France"},{"name":"Universit\u00e9 de Franche-Comt\u00e9, LNIT (Laboratoire de Nanom\u00e9decine, Imagerie, Th\u00e9rapeutique EA 4662) , F-25000 Besan\u00e7on , France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2023,12,10]]},"reference":[{"key":"2024011211321203300_CIT0001","first-page":"610544","article-title":"Perinatal derivatives: where do we stand? A roadmap of the human placenta and consensus for tissue and cell nomenclature","volume-title":"Front Bioeng Biotechnol","author":"Silini","year":"2020"},{"issue":"1","key":"2024011211321203300_CIT0002","first-page":"307","article-title":"Skin transplantation with a review of 550 cases at the John Hopkins Hospital","volume":"15","author":"Davis","year":"1910","journal-title":"John Hopkins Med J."},{"key":"2024011211321203300_CIT0003","first-page":"1174","article-title":"Hematopoietic reconstitution in a patient with Fanconi\u2019s anemia by means of umbilical-cord blood from an HLA-identical sibling","volume-title":"N Engl J Med","author":"Gluckman","year":"1989"},{"key":"2024011211321203300_CIT0004"},{"key":"2024011211321203300_CIT0005","first-page":"108","article-title":"Protecting the health and safety of cell and tissue donors","volume-title":"ISBT Sci Ser","author":"Stroncek","year":"2015"},{"key":"2024011211321203300_CIT0006","first-page":"5097","article-title":"Practice patterns for evaluation, consent, and care of related donors and recipients at hematopoietic cell transplantation centers in the United States","volume-title":"Blood","author":"O\u2019Donnell","year":"2010"},{"key":"2024011211321203300_CIT0007","first-page":"40"},{"key":"2024011211321203300_CIT0008"},{"key":"2024011211321203300_CIT0009"},{"key":"2024011211321203300_CIT0010"},{"issue":"3-4","key":"2024011211321203300_CIT0011","first-page":"85","article-title":"Amnion allografts prepared in the Central Tissue Bank in Warsaw","volume":"4","author":"Tyszkiewicz","year":"1999","journal-title":"Ann Transplant"},{"key":"2024011211321203300_CIT0012","first-page":"1E.10.1","article-title":"Isolation of human amnion epithelial cells according to current good manufacturing procedures","volume-title":"Curr Protoc Stem Cell Biol","author":"Gramignoli","year":"2016 12"},{"key":"2024011211321203300_CIT0013"},{"key":"2024011211321203300_CIT0014","first-page":"2319","article-title":"Good design practices for an integrated containment and production system for advanced therapies","volume-title":"Biotechnol Bioeng","author":"Zanini","year":"2020"},{"key":"2024011211321203300_CIT0015","first-page":"977590","article-title":"Perinatal derivatives application: identifying possibilities for clinical use","volume-title":"Front Bioeng Biotechnol","author":"Gindraux","year":"2022"},{"key":"2024011211321203300_CIT0016"},{"key":"2024011211321203300_CIT0017","first-page":"601","article-title":"A risk-based approach to setting sterile filtration bioburden limits","volume-title":"PDA J Pharm Sci Technol","author":"Yang","year":"2013"},{"key":"2024011211321203300_CIT0018","year":"2007"},{"key":"2024011211321203300_CIT0019"},{"key":"2024011211321203300_CIT0020","first-page":"799","article-title":"The effect of repeated freeze-thaw cycles on human muscle tissue visualized by postmortem computed tomography (PMCT)","volume-title":"Clin Anat","author":"Klop","year":"2017"},{"key":"2024011211321203300_CIT0021","first-page":"303","article-title":"Amniotic membrane transplantation for persistent epithelial defects with ulceration","volume-title":"Am J Ophthalmol","author":"Lee","year":"1997"},{"key":"2024011211321203300_CIT0022","first-page":"235","article-title":"Transplantation of amniotic membrane and limbal autograft for patients with recurrent pterygium associated with symblepharon","volume-title":"Br J Ophthalmol","author":"Shimazaki","year":"1998"},{"key":"2024011211321203300_CIT0023","first-page":"1","article-title":"The influence of various storage conditions on cell viability in amniotic membrane","volume-title":"Cell Tissue Bank","author":"Hennerbichler","year":"2007"},{"key":"2024011211321203300_CIT0024","first-page":"4029","article-title":"Repeated freezing procedures preserve structural and functional properties of amniotic membrane for application in ophthalmology","volume-title":"Int J Mol Sci","author":"Pogozhykh","year":"2020"},{"key":"2024011211321203300_CIT0025","first-page":"57","article-title":"Application of sterilised human amnion for reconstruction of the ocular surface","volume-title":"Cell Tissue Bank","author":"Von Versen-H\u00f6ynck","year":"2004"},{"key":"2024011211321203300_CIT0026","first-page":"95","article-title":"Properties of air dried radiation processed amniotic membranes under different storage conditions","volume-title":"Cell Tissue Bank","author":"Singh","year":"2003"},{"key":"2024011211321203300_CIT0027","first-page":"355","article-title":"Radiation sterilization of tissue allografts: a review","volume-title":"World J Radiol","author":"Singh","year":"2016  28"},{"key":"2024011211321203300_CIT0028","first-page":"330","article-title":"Endogenous viable cells in lyopreserved amnion retain differentiation potential and anti-fibrotic activity in vitro","volume-title":"Acta Biomater","author":"Mao","year":"2019"},{"key":"2024011211321203300_CIT0029","first-page":"37","article-title":"The measurement of water activity in allogeneic skin grafts preserved using high concentration glycerol or propylene glycol","volume-title":"Cell Tissue Bank","author":"Ross","year":"2004"},{"key":"2024011211321203300_CIT0030","first-page":"3","article-title":"Banking of non-viable skin allografts using high concentration of glycerol or propylene glycol","volume-title":"Cell Tissue Bank","author":"Huang","year":"2004"},{"key":"2024011211321203300_CIT0031","first-page":"95","article-title":"Physical changes of amniotic membranes through glycerolization for the use as an epidermal substitute Light and electron microscopic studies","volume-title":"Cell Tissue Bank","author":"Rejzek","year":"2001"},{"key":"2024011211321203300_CIT0032","first-page":"453","article-title":"Evaluation of bone marrow-derived mesenchymal stem cells after cryopreservation and hypothermic storage in clinically safe medium","volume-title":"Tissue Eng Part C Methods","author":"Ginis","year":"2012"},{"key":"2024011211321203300_CIT0033","first-page":"215","article-title":"Characterization and modulation of human mesenchymal stem cell stress pathway response following hypothermic storage","volume-title":"Cryobiology","author":"Corwin","year":"2014"},{"key":"2024011211321203300_CIT0034","first-page":"2691","article-title":"Cryostorage of mesenchymal stem cells and biomedical cell-based products","volume-title":"Cells","author":"Linkova","year":"2022"},{"key":"2024011211321203300_CIT0035","first-page":"104","article-title":"Me2SO- and serum-free cryopreservation of human umbilical cord mesenchymal stem cells using electroporation-assisted delivery of sugars","volume-title":"Cryobiology","author":"Mutsenko","year":"2019"},{"key":"2024011211321203300_CIT0036","first-page":"264","article-title":"Magnetic induction heating of superparamagnetic nanoparticles during rewarming augments the recovery of hUCM-MSCs cryopreserved by vitrification","volume-title":"Acta Biomater","author":"Wang","year":"2016"},{"key":"2024011211321203300_CIT0037","first-page":"1696","article-title":"Effects of cryogenic storage on human amnion epithelial cells","volume-title":"Cells","author":"Srinivasan","year":"2020"},{"key":"2024011211321203300_CIT0038","first-page":"93","article-title":"Cryobiological parameters of multipotent stromal cells obtained from different sources","volume-title":"Cryobiology","author":"Lauterboeck","year":"2017"},{"key":"2024011211321203300_CIT0039","first-page":"77","article-title":"Cryopreserved or fresh mesenchymal stromal cells: only a matter of taste or key to unleash the full clinical potential of MSC therapy?","volume-title":"Adv Exp Med Biol","author":"Moll","year":"2016"},{"key":"2024011211321203300_CIT0040","first-page":"147","article-title":"Cryopreserved mesenchymal stromal cells display impaired immunosuppressive properties as a result of heat-shock response and impaired interferon-\u03b3 licensing","volume-title":"Cytotherapy","author":"Fran\u00e7ois","year":"2012"},{"key":"2024011211321203300_CIT0041","first-page":"1627","article-title":"The utilization of freezing steps in mesenchymal stromal cell (MSC) manufacturing: potential impact on quality and cell functionality attributes","volume-title":"Front Immunol","author":"Oja","year":"2019"},{"key":"2024011211321203300_CIT0042","first-page":"38","article-title":"Clinical mesenchymal stromal cell products undergo functional changes in response to freezing","volume-title":"Cytotherapy","author":"Pollock","year":"2015"},{"key":"2024011211321203300_CIT0043","first-page":"2429","article-title":"Cryopreserved mesenchymal stromal cells are susceptible to T-cell mediated apoptosis which is partly rescued by IFN\u03b3 licensing","volume-title":"Stem Cells","author":"Chinnadurai","year":"2016"},{"key":"2024011211321203300_CIT0044","first-page":"773123","article-title":"Banking of AT-MSC and its influence on their application to clinical procedures","volume-title":"Front Bioeng Biotechnol","author":"Semenova","year":"2021"},{"key":"2024011211321203300_CIT0045","first-page":"181","article-title":"Mesenchymal stromal cells derived from various tissues: biological, clinical and cryopreservation aspects","volume-title":"Cryobiology","author":"Marquez-Curtis","year":"2015"},{"key":"2024011211321203300_CIT0046","first-page":"72","article-title":"Impact of cryopreservation and freeze-thawing on therapeutic properties of mesenchymal stromal\/stem cells and other common cellular therapeutics","volume-title":"Curr Stem Cell Rep","author":"Cottle","year":"2022"},{"key":"2024011211321203300_CIT0047","first-page":"113","article-title":"Evaluation of different routes of administration and bio-distribution of human amnion epithelial cells in mice","volume-title":"Cytotherapy","author":"Srinivasan","year":"2019"},{"key":"2024011211321203300_CIT0048","first-page":"2","article-title":"The mesenchymal stromal cells dilemma--does a negative phase III trial of random donor mesenchymal stromal cells in steroid-resistant graft-versus-host disease represent a death knell or a bump in the road","volume-title":"Cytotherapy","author":"Galipeau","year":"2013"},{"key":"2024011211321203300_CIT0049","first-page":"114","article-title":"New approach to cryopreservation of primary noncultivated human umbilical vein endothelium in biobanking","volume-title":"Biopreserv Biobank","author":"Puzanov","year":"2018"},{"key":"2024011211321203300_CIT0050","first-page":"581","article-title":"Membrane vesicles as conveyors of immune responses","volume-title":"Nat Rev Immunol","author":"Th\u00e9ry","year":"2009"},{"key":"2024011211321203300_CIT0051","first-page":"1909125","article-title":"\u201cBiomaterials functionalized with MSC secreted extracellular vesicles and soluble factors for tissue regeneration\u201d","volume-title":"Adv Funct Mater","author":"Brennan","year":"2020"},{"key":"2024011211321203300_CIT0052","first-page":"878","article-title":"\u201cMonocyte-derived microparticles and exosomes induce procoagulant and apoptotic effects on endothelial cells\u201d","volume-title":"Thromb Haemost","author":"Aharon","year":"2008"},{"key":"2024011211321203300_CIT0053","first-page":"1604","article-title":"Tissue-factor-bearing microvesicles arise from lipid rafts and fuse with activated platelets to initiate coagulation","volume-title":"Blood","author":"Del Conde","year":"20051"},{"key":"2024011211321203300_CIT0054","article-title":"Principles of Microbiological Testing, Chapter 11","volume-title":"Guide to the Quality and Safety of Tissues and Cells for Human Application","year":"2022","edition":"5"},{"key":"2024011211321203300_CIT0055","volume-title":"Sterility, General Chapter, 2.6.1 Ph. Eur","year":"2020","edition":"10"},{"key":"2024011211321203300_CIT0056","volume-title":"Guidelines for Using the Test for Sterility, General Chapter, 5.1.9 Ph. Eur","year":"2020","edition":"10"},{"key":"2024011211321203300_CIT0057","volume-title":"Microbiological Examination of Non-Sterile Products (Total Viable Aerobic Count), General Chapter 2.6.12 Ph. Eur","year":"2020","edition":"10"},{"key":"2024011211321203300_CIT0058","volume-title":"Microbiological Examination of Non-Sterile Products (Test for Specified Micro-Organisms), General Chapter 2.6.13. Ph. Eur","year":"2020","edition":"10"},{"key":"2024011211321203300_CIT0059","volume-title":"Mycoplasmas, General Chapter. 2.6.7 Ph. Eur","year":"2020","edition":"10"},{"key":"2024011211321203300_CIT0060","volume-title":"Bacterial Endotoxins, General Chapter. 2.6.14 Ph. Eur","year":"2020","edition":"10"},{"key":"2024011211321203300_CIT0061","volume-title":"Guidelines for Using the Test for Bacterial Endotoxins, General Chapter. 5.1.10 Ph. Eur","year":"2020","edition":"10"},{"key":"2024011211321203300_CIT0062","first-page":"961987","article-title":"General consensus on multimodal functions and validation analysis of perinatal derivatives for regenerative medicine applications","volume-title":"Front Bioeng Biotechnol","author":"Pozzobon","year":"2022"},{"key":"2024011211321203300_CIT0063","first-page":"641","article-title":"Mesenchymal stem cells","volume-title":"J Orthop Res","author":"Caplan","year":"1991"},{"key":"2024011211321203300_CIT0064","first-page":"1445","article-title":"Mesenchymal stem cells: time to change the name!","volume-title":"Stem Cells Transl Med","author":"Caplan","year":"2017"},{"key":"2024011211321203300_CIT0065","first-page":"1019","article-title":"Mesenchymal stem versus stromal cells: International Society for Cell & Gene Therapy (ISCT\u00ae) Mesenchymal Stromal Cell committee position statement on nomenclature","volume-title":"Cytotherapy","author":"Viswanathan","year":"2019"},{"key":"2024011211321203300_CIT0066","first-page":"315","article-title":"Minimal criteria for defining multipotent mesenchymal stromal cells The International Society for Cellular Therapy position statement","volume-title":"Cytotherapy","author":"Dominici","year":"2006"},{"key":"2024011211321203300_CIT0067","doi-asserted-by":"crossref","first-page":"652034","DOI":"10.1155\/2012\/652034","article-title":"Safety of mesenchymal stem cells for clinical application","volume":"2012","author":"Wang","year":"2012","journal-title":"Stem Cells Int"},{"key":"2024011211321203300_CIT0068","first-page":"120","article-title":"Mesenchymal stem cells: from biology to clinical use","volume-title":"Blood Transfus","author":"Krampera","year":"2007"},{"key":"2024011211321203300_CIT0069","first-page":"Unit 1E.6","article-title":"Amnion epithelial cell isolation and characterization for clinical use","volume-title":"Curr Protoc Stem Cell Biol","author":"Murphy","year":"2010"}],"container-title":["Stem Cells Translational Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/stcltm\/article-pdf\/13\/1\/14\/55558943\/szad068.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/stcltm\/article-pdf\/13\/1\/14\/55558943\/szad068.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T11:33:20Z","timestamp":1705059200000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/stcltm\/article\/13\/1\/14\/7468196"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,10]]},"references-count":69,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,12,10]]},"published-print":{"date-parts":[[2024,1,12]]}},"URL":"https:\/\/doi.org\/10.1093\/stcltm\/szad068","relation":{},"ISSN":["2157-6564","2157-6580"],"issn-type":[{"value":"2157-6564","type":"print"},{"value":"2157-6580","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,1,1]]},"published":{"date-parts":[[2023,12,10]]}}}